LAVAL, QC, Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced the presentation of three posters during the 2022 American Academy of Dermatology (AAD) Annual Meeting, which takes place March 25-29, 2022.
The presentations will feature new analyses of the investigational medicine IDP-126 Gel and the efficacy of DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, as well as results from multiple studies assessing the efficacy of SILIQ® (brodalumab) Injection for the treatment of nail and scalp psoriasis. Ortho Dermatologics will also unveil a new JUBLIA® (efinaconazole) Topical Solution, 10% virtual reality (VR) experience in the company’s booth (#917).
- Three Poster Presentations Will Include New Analyses on IDP-126 Gel, DUOBRII® and SILIQ®
- Company Will Introduce New JUBLIA® Virtual Reality Experience in Booth
“At this year’s AAD meeting, we look forward to sharing new data on our investigational acne medicine, IDP-126 Gel, as well as new analyses on two of our psoriasis medicines, DUOBRII and SILIQ,” said Joseph C. Papa, chairman and CEO, Bausch Health. “We will also introduce the JUBLIA® virtual reality experience, which was designed to provide insight into onychomycosis, a condition that affects as many as 35 million people in the United States each year and highlights the benefits of using JUBLIA® as a treatment option.”
One poster presentation will feature new analyses of the investigational medicine IDP-126 Gel, a combination retinoid, anti-bacterial and antibiotic topical, including new safety and efficacy results from a Phase 2 and two Phase 3 studies on participants with moderate-to-severe acne. If approved, IDP-126 would be the first-in-class treatment with this triple combination.
The second presentation will highlight the efficacy results of DUOBRII® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% in maintaining skin clearance in a long-term open-label study evaluating participants with prior use of topical treatments.
The last presentation will provide the results from multiple studies assessing the efficacy of SILIQ® (brodalumab) Injection for the treatment of nail and scalp psoriasis and how these results may differ by gender. Please see below for Boxed Warning about suicidal ideation and behavior with SILIQ.
For the first time at the AAD annual meeting, attendees will have the opportunity to explore onychomycosis from beneath the toenail through the JUBLIA® Virtual Reality Experience. This immersive experience will be offered through virtual reality goggles to detail the condition and demonstrate how JUBLIA® (efinaconazole) Topical Solution, 10%, which received the American Podiatric Medical Association (APMA) Seal of Approval in December 2021, can be used as an effective treatment option.
The complete list of poster presentations that will be presented is as follows:
IDP-126 Gel (Investigational Drug)
“Efficacy and Safety of a Fixed-Dose Clindamycin 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: Randomized Phase 2 and Phase 3 Studies of the First Triple-Combination Drug.” Stein Gold et al.
DUOBRII® (halobetasol propionate and tazarotene) Lotion
“Maintenance of Skin Clearance in a Long-term Open-label Study of Fixed-Combination Halobetasol Propionate and Tazarotene Lotion for Psoriasis in Participants With Prior Use of Topical Treatments.” Stein Gold et al.
SILIQ® (brodalumab) Injection
“Analysis of Nail or Scalp Psoriasis by Gender in Clinical Studies of Brodalumab.” Elewski et al.
Important Safety Information for SILIQ (brodalumab) Injection
What is SILIQ?
SILIQ® injection is a prescription medicine used to treat adults with moderate to severe plaque psoriasis:
who may benefit from injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light treatment) and who have tried another systemic therapy that didn’t work or stopped working
It is not known if SILIQ is safe and effective in children.
What is the most important information I should know about SILIQ?
Suicidal thoughts or behavior: Some patients taking SILIQ have had suicidal thoughts or ended their own lives. This risk is higher if you have a history of suicidal thoughts or depression. It is not known if SILIQ causes these thoughts or actions. Get medical help right away if you or a family member notices that you have any of the following symptoms:
new or worsening depression, anxiety, or mood problems thoughts of suicide, dying, or hurting yourself attempt to commit suicide, or acting on dangerous impulses other unusual changes in your behavior or mood
Your healthcare provider will give you a SILIQ patient/wallet card about symptoms that need medical attention right away. Carry the card with you during treatment with SILIQ and show it to all of your healthcare providers.
Serious Infections: SILIQ may lower the ability of your immune system to fight infections and may increase your risk of infections:
Your healthcare provider should check you for tuberculosis (TB) before starting treatment with SILIQ and may treat you for TB before starting SILIQ if you have TB or a history of it You and your healthcare provider need to watch closely for signs and symptoms of infection during treatment with SILIQ, including fever, sweats, chills, shortness of breath, stomach issues, muscle aches, cough, sore throat or trouble swallowing, warm/red/painful skin sores, burning while urinating or more frequent urination
Who should not use SILIQ?
Do not use SILIQ if you have Crohn’s disease. Tell your healthcare provider if you develop diarrhea, bloody stools, stomach pain or cramping, sudden or uncontrollable bowel movements, loss of appetite, constipation, weight loss, fever or tiredness as these may be symptoms of Crohn’s disease.
Before starting SILIQ, tell your healthcare provider if you:
have a history of mental health problems, including suicidal thoughts, depression, anxiety, or mood problems have an infection that does not go away or keeps coming back have TB or have been in close contact with someone with TB have recently received or are scheduled to receive an immunization (vaccine). You should avoid getting live vaccines while being treated with SILIQ are or plan to become pregnant or are breastfeeding or plan to do so. It is unknown if SILIQ can harm your unborn or newborn baby
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use SILIQ?
See the detailed “Instructions for Use” that come with your SILIQ for information on the right way to store, prepare, and give your SILIQ injections at home, and how to properly throw away (dispose of) used SILIQ prefilled syringes. Use SILIQ exactly as your healthcare provider tells you to use it.
What are possible side effects of SILIQ?
SILIQ may cause serious side effects. See “What is the most important information I should know about SILIQ?” and “Who should not take SILIQ?”
The most common side effects of SILIQ include:
- Joint pain
- Muscle pain
- Headache
- Injection site reactions
- Tiredness
- Flu
- Diarrhea
- Low white blood cell count (neutropenia)
- Mouth or throat pain
- Fungal infections of the skin
- Nausea
